Missouri Board Of Pharmacy

Transcription

1 Missouri Board Of Pharmacy Board Update September 13, 2015 Tom Glenski, R.Ph. Andi Miller, PharmD Chief Inspector Inspector

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3 Program Objectives Identify recent regulatory and statutory changes for licensees Outline how to increase compliance with Missouri's regulatory requirements Identify available compliance resources for licensees

4 Program Design 2015 and 2016 legislative session 2015 regulations Compliance resources for licensees Board news Questions

5 Pre-Assessment Questions True or False 1. In 2015 Missouri passed legislation creating a prescription drug monitoring program. 2. Hospitals no longer need a distributor license to distribute drugs to other hospitals. 3. The Board is working on revising the sterile compounding rule. 4. Thiotepa is an example of a drug FDA has approved importation to alleviate a shortage. 5. A physician s office may distribute drugs to a hospital without a distributor license.

6 2015 Legislative Session

7 Pharmacy Related Legislative Proposals Prescription Monitoring Program (PMP) aka Prescription Drug Monitoring Program (PDMP) Four proposals Privacy issues Funding issues (Did not pass)

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9 Pharmacy Related Legislative Proposals Medication synchronization MAC pricing Medical marijuana (Did not pass)

10 Board Legislation Reporting of disciplinary actions Non-resident renewals Statistical reporting (Did not pass)

11 Successful Legislation HB 709 Extends prescriptive authority for APRNs, PAs & Assistant Physicians to Schedule II hydrocodone products. Five day supply limit. Effective August 28, 2015

12 ? 2016? Expansion of pharmacist clinical/ immunization services Medicaid expansion PMP MAC pricing Medication synchronization Medical marijuana

13 2016 Board Proposals Non-resident renewals Mandatory disciplinary reporting Charitable pharmacy Immunization Grounds for discipline Drug outsourcers and third party logistics providers

14 2015 Regulation Activity

15 2015 Regulation Activity Revised 20 CSR Drug Distributor Licensing Requirements Revisions in process 20 CSR General Fees 20 CSR Pharmacy Technician Registration 20 CSR Medication Therapy Services by Protocol

16 20 CSR Drug Distributor Licensing Requirements 5/30/2015 effective date 5% gross sales rule Redefined for pharmacies that have no sales Now includes 5% of pharmacies total drug purchase

17 20 CSR Drug Distributor Licensing Requirements No distributor license required for: Hospital to hospital Hospital to health care entity under common control or ownership Alleviate drug shortage from FDA approved importer or manufacturer SNS or state emergency stockpile Out of state pharmacy licensed in home state

18 20 CSR Drug Distributor Licensing Requirements Caution: BNDD/DEA and other state s requirements still apply

19 Hospitals Other hospitals (licensed by DHSS or operated by the state) Health care entity under common control or ownership Offsite pharmacy Offsite practitioner Offsite clinic Ambulatory surgery center Ambulance

20 Hospitals Entities not under common control/ownership X Independent and chain pharmacies X Private physician practices X Entities leasing/renting space at hospital X Other hospital s healthcare entities X Public ambulance districts X Local health departments If questions, contact your legal counsel

21 Hospitals Distribution is from hospital not X Clinic to hospital X Ambulatory surgery center to hospital Does not include further distribution within health system X Practitioner to other entities X Clinic to other entities

22 Drug shortage FDA approved importer or manufacturer FDA drug shortages website Example: Thiotepa Maintain documentation of FDA authorization

23 Out of state (OOS) pharmacies MO pharmacy may receive drug from OOS pharmacy holding no MO license MO pharmacy must maintain records: Proof of OOS pharmacy s home state licensure Distribution record (invoice) Name/address of OOS pharmacy Date of distribution Drug name/strength/quantity Two years Purchase limit: 5% of limit MO pharmacy s annual Rx sales

24 Out of state (OOS) pharmacies Caution: BNDD/DEA records and licensure requirements still apply Other state s licensure requirements may apply to MO pharmacy shipping into their state

25 20 CSR General Fees Revision in process Fee reductions Permanent

26 20 CSR Pharmacy Technician Licensure Revision in process List of prohibitive acts Requires documented training

27 20 CSR Medication Therapy Services by Protocol Revision in process (staled since 2012)

28 Other Board Regulation Activity

29 Other Regulation Activity Board is working on: New Return for destruction Revisions Pharmacist-in-charge responsibilities Class J shared pharmacy services Sterile compounding Pharmacist administration

30 Presented by Andi Miller, PharmD, Inspector COMPLIANCE TOOLS

31 Areas of compliance General Immunizations Individual professions Specific questions

32 Board of Pharmacy website

33 Sign up for e-alerts Send with Subscribe in subject heading Quarterly newsletters E-alerts

34 Pharmacy Practice Guide

35 Self-assessment

36 Webinars Register for live webinars Quarterly Lunch with the Chief Free CE Watch previous recordings on demand 2011 to present No CE

37 Immunization FAQs

38 Immunization Checklist

39 Notification of Intent

40 PIC: FAQs

41 PIC: pharmacy compliance Compliance Top 10 Self-Assessment Practice specific guides (MTS, sterile, vet)

42 PIC: verifying work eligibility Licensee search Active licensure Discipline history Notification of intent status HB 600 list Technician disqualification list Conditional registration list

43 Interns: FAQs

44 Intern: guide for students

45 Technicians Technician guide Quiz Free Anonymous 30 questions 75% required to pass

46 Specific questions Searchable pdf s Law book Compliance guides Ask! Inspector Board office

47 Board News

48 Board News New Board members Christina Lindsay Kansas City Christian Tadrus Moberly Douglas Lang St. Louis New office employees Compliance coordinator activities Jennifer Luebbert New ninth inspector position Kansas City inspector opening

49 Board News New licensing system New electronic inspection program Upcoming events Board meeting - October 14 - Columbia Lunch with the Chief Webinar October 13

50 Post-Assessment Questions 1. In 2015 Missouri passed legislation creating a prescription drug monitoring program. FALSE 2. Hospitals no longer need a distributor license to distribute drugs to other hospitals. TRUE 3. The Board is working on revising the sterile compounding rule. TRUE 4. Thiotepa is an example of a drug FDA has approved importation to alleviate a shortage. TRUE 5. A physician s office may distribute drugs to a hospital without a distributor license. FALSE

51 QUESTIONS

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